Romidepsin for T-Cell Lymphoma
Untitled Document
Name of the Trial
Phase II Study of FR901228 (Depsipeptide) in Patients with Cutaneous T-Cell
Lymphoma, Relapsed Peripheral T-Cell Lymphoma, or Other Mature T-Cell Lymphoma
(NCI-01-C-0049). See the protocol
summary.
Principal Investigators
Dr. Susan E. Bates and Dr. Richard Piekarz, NCI Center for Cancer Research.
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Drs. Susan Bates and Richard Piekarz
Principal Investigator |
Why This Trial Is Important
Principal investigators for this phase II trial, which was first featured in
the January 13, 2004, issue of the NCI Cancer Bulletin, are seeking additional
patients with cutaneous T-cell lymphoma to form a new study population, or cohort.
"Because of the promising responses we've seen in the first cohort of
this study, we've opened a new cohort specifically for patients with cutaneous
T-cell lymphoma who have had two or fewer prior chemotherapy regimens,"
said Dr. Piekarz.
With this trial, researchers are seeking to determine whether romidepsin (FR901228,
depsipeptide), a histone deacetylase inhibitor, can help bring about remission
in patients with T-cell lymphoma.
"This trial is very exciting because it involves a new class of anticancer
drugs that can change the way cells grow," said Dr. Bates. "Whereas
many chemotherapy drugs work by causing damage to cells, histone deacetylase
inhibitors like romidepsin turn on genes in cancer cells that inhibit cell growth
and eventually cause the cancer cells to die."
"We are continuing to see a complete or partial response rate between
30 and 40 percent for patients with cutaneous T-cell lymphoma," Dr. Piekarz
said. "And the response rate for patients with peripheral T-cell lymphoma
has remained steady at 25 percent."
Who Can Join This Trial
Researchers seek to enroll a total of 197 patients aged 18 and over who have
cutaneous T-cell lymphoma, peripheral T-cell lymphoma, or other mature T-cell
lymphomas. See the full list
of eligibility criteria for this trial.
Study Sites and Contact Information
Multiple study sites are enrolling patients in this trial. See the list
of study contacts or call the NCI's Clinical Trials Referral Office at 1-888-NCI-1937
(1-888-624-1937). The call is toll free and completely confidential.
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